Pixantrone (BBR 2778) in Patients With Refractory Acute Myelogenous Leukemia (AML)

This is an open label, single center, phase I/II study of pixantrone in patients with refractory AML. Pixantrone will be administered for three consecutive days on days 1, 2 and 3 of each 21-day cycle, for up to two cycles. The study has 2 parts; phase I and phase II. In the phase I part of the study, the maximum tolerated dose (MTD) for pixantrone as a single agent in patients with refractory AML will be determined. In the phase II part of the study, up to an additional 86 patients will be treated at the MTD to assess disease response.